How we validate new laboratory reagents

Nuevos reactivos de laboratorio

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Laboratory validation of reagents is essential to ensure the accuracy and reliability of test results. Reagents are chemical substances and biologicals used in laboratory tests to detect, measure or identify a specific substance or pathogen. Reagent quality directly affects accuracy and reliability of test results, it is therefore important to ensure that the reagents used in the laboratory are valid and within the established quality limits.

This involves a detailed process of selection, preparation, testing and evaluation of reagents prior to their use in the laboratory, including ensuring that reagents are of high quality and meet established standards, as well as ensuring that reagents are properly prepared and stored. In addition, it is important to perform regular tests to ensure that the reagents remain valid and within quality limits. This means that they can be included in certification and accreditation procedures that guarantee the quality of the results.


Steps for the validation of new laboratory reagents

Validation of new reagents in a laboratory involves the following steps:

validation of new reagents

  1. Needs assessment: ask yourself the necessary questions.
  2. Selection of the supplier: ensure that all materials required are sourced from a reliable supplier and previously accredited by our Laboratory.. It is necessary to review the documentation that assures us of the quality of the product.
  3. Testing: in order to study and verify that the new reagent meets the requirements set out in our quality system assessment and verification procedures.
  4. Evaluation of results: test results are interpreted and compared with established standards to determine whether the new reagent meets quality requirements.
  5. Implementation: if the new reagent has been approved, it is incorporated into the laboratory and staff are trained in its proper use and storage.
  6. Continuous monitoring: regular tests are performed to ensure that the new reagent continues to meet quality requirements despite the passage of time. Utilización de controles internos y externos.


Types of tests to validate new laboratory reagents


There are several types of tests that can be used to validate new reagents in a laboratory. Some of them are:

  • Specification tests: these are performed to verify that the reagent meets required needs such as content, purity, pH, stability, among others.
  • Performance tests are performed to compare the reagent being validated against existing reagents or reference standards. These tests may include sensitivity, specificity, precision, accuracy, linearity, among others.
  • Stability tests: these are carried out to determine the shelf life. This may include accelerated ageing tests, storage tests and stability tests under different temperature and humidity conditions.
  • Interference tests: these are performed to evaluate how the reagent behaves towards substances that may interfere with the test, such as components of the reaction flask or components of the serum or plasma.
  • Compatibility tests are performed to assess whether the new reagent is compatible with other reagents and equipment used in the laboratory.
  • Cross-validation tests: are performed to assess the agreement between different methods or test systems.

It is important to mention that not all tests are necessary to validate each new reagent and the tests required may vary depending on the type of reagent and the purpose for which it is used.

At Ambar Lab we validate new laboratory reagents by the hand of our specialised team to ensure a proper and safe procedure at all times.

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